Field trial and intervention studies

Dr Saad Omer, Emory University, Atlanta, USA

Wednesday 4 – Friday 6 June 2014

Lecture Room 5, Bristo Square, The University of Edinburgh

Full delegate fee £350. Subsidised fee £220
(for further details of subsidised places please contact l.marshall@ed.ac.uk)

BOOK NOW

Programme
	Wednesday	Thursday	Friday
8.30am – 9.15am	Registration
9.15am – 9.30am	Course overview	Group discussion/exercises (Trial Concept sheets prepared by the students)	Group discussion/exercises (Time for preparing group presentations)
9.30am – 11.00am	Session 1 (Introduction to Field Trials)
11.00am – 11.30am	Refreshment Break	Refreshment Break	Refreshment Break
11.30am – 1.00pm	Session 2 (Trial Designs & Planning a Field Trial)	Session 5 (Data Management)	Group discussion/exercises (Presentation and structured group discussion of trial outline prepared by the students)
		Session 6 (Analysis of Field Trial Data)
1.00pm – 2.00pm	Lunch/Networking	Lunch/Networking	Lunch/Networking
2.00pm – 3.30pm	Session 3 (Sample Size and Power)	Session 7 (Ethical and Regulatory Issues)	Session 8 (Adverse Event Monitoring and DSMB)
3.30pm – 4.00pm	Refreshment Break	Refreshment Break	Refreshment Break
4.00pm – 5.30pm	Session 4 (Conducting a Field Trial)	Group discussion/exercises (Time for preparing group presentations)	Session 9 (Disseminating Results and Influencing Practice and Policy)

Overview

Requirements: A basic knowledge of epidemiology.

This course will develop understanding of design, conduct, and analysis of field trials and intervention studies. The course will focus on methods relevant to community and facility based trials in resource poor settings. However, several skills covered in this course will also be applicable to field and clinical trials in developed countries.

Upon completion of their course work, the students will be able to

Design programs, policies and/or interventions intended to improve health services and health status of individuals, communities, and populations
Conduct research, including formulation of specific research aim, conducting a literature review and formulating a hypothesis and selecting appropriate methodologies related to the emphasis
Implement strategies to prevent and control infectious diseases

also

Design a simple field trial
Outline trial objectives and primary and secondary endpoints
Compute sample size and estimate power
Outline eligibility criteria
Choose appropriate population
Develop randomization and masking procedures
Outline enrollment and follow up procedures
Analyze trial data including data for interim analysis
Design case report forms and outline a trial data management system
Describe regulatory requirements for conducting trials
Develop consent forms and informed consent procedures
Develop a study oversight plan; including plan for a Data Safety Monitoring Board (DSMB)
Write a report of study results per CONSORT guidelines

Tutor

Saad B Omer, MBBS MPH PhD
somer@emory.edu

Textbooks

Primary Text:
Field Trials of Health Interventions in Developing Countries: A Toolbox
–Peter Smith & Richard Morrow
Additional Reading:
Clinical Trials: A Practical Guide to Design, Analysis, and Reporting
–Duolao Wang & Ameet Bakhai

lifelong template unused